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OpenTrials
Active, Not Recruiting

NCT Number: NCT04805970

REsearching Covid-19 Outcomes in Diabetes (RECODE)

The purpose of this study is to observe any changes that may occur to certain organs following a confirmed diagnosis of COVID-19 in people with and without diabetes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For Type 2 Diabetes (T2D)

  • Male or female 18 years of age and older willing and able to give informed consent to participate in the study
  • Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
  • Diagnosis of T2D according to American Diabetes Association (ADA) criteria.
  • Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.

For participant without Type 2 Diabetes (T2D)

  • Male or female 18 years of age and older willing and able to give informed consent to participate in the study
  • Confirmed diagnosis of SARS-CoV-2 RNA via a polymerase chain reaction (PCR) assay (having been discharged at least 2 months from hospital but not greater than 6 months).
  • Must have access to a computer/laptop or a modern (no more than 3-4 years old) smart phone/tablet for cognitive assessments.

Exclusion criteria

  • Symptoms of active respiratory viral infection:
  • high temperature (over 37.8°C/100.4°F)
  • cough (consistent for over an hour; 3 or more episodes in 24 hours)
  • Any history of Type I diabetes
  • The participant may not enter the study with any known contraindication to magnetic resonance imaging including
  • Pregnancy, lactation or 6 months postpartum from the scheduled date of collection
  • Metal implants (pacemaker, aneurysm clips) based on Investigator's judgment at Screening
  • Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at Screening
  • Unable to tolerate MRI imaging or claustrophobia
  • Any condition, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.

Treatment and study plan

Primary outcomes

  1. Measure and characterize organ volume change in patients with and without diabetes through use of summary statistics.

    Time frame: 1 year

    Patients recovering from the COVID-19 disease

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Registry information

Acronym: RECODE

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Mar 18, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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